Surgical helical fastener with applicator

ABSTRACT

A helical fastener having a high retentive surface area is provided and has a first end for enhancing penetration into tissue and a second end comprising a coil sectioning a diameter of the fastener for receiving longitudinal and rotational forces. The helical fasteners are attached to body tissue by a fastener applicator having a proximal portion comprising a handle and an actuator and an elongate distal portion for housing a plurality of fasteners. A transferring action of the actuator provides longitudinal and rotational movement of the fasteners out of the distal portion and into body tissue.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. application Ser. No.10/330,903, filed Dec. 27, 2002, now U.S. Pat. No. 6,884,248, which is acontinuation of U.S. application Ser. No. 09/968,100, filed on Oct. 1,2001, now U.S. Pat. No. 6,562,051, which is a continuation of U.S.application Ser. No. 08/499,279, filed on Jul. 7, 1995, now U.S. Pat.No. 6,296,656, which is a divisional of U.S. application Ser. No.08/286,878, filed on Aug. 5, 1994, now U.S. Pat. No. 5,582,616. Thepriority of these prior applications is expressly claimed and theirdisclosures are hereby incorporated by reference in their entirety.

BACKGROUND OF THE INVENTION

This invention relates to surgical fasteners and their associatedapplicators, and more particularly, surgically fastening material totissue.

Fasteners have been used surgically to eliminate the need for suturing,which is both time consuming and inconvenient. In many applications thesurgeon can use a stapler apparatus, i.e., a fastener implanting deviceloaded with surgical fasteners to accomplish in a few seconds what wouldhave taken many minutes to perform by suturing. This reduces blood lossand trauma to the patient.

Conventional surgical fasteners have been in the form of ordinary metalstaples, which are bent by the delivery apparatus to hook together bodytissue. Typically, conventional staples comprise a pair of legs joinedtogether at one end by a crown. The crown may be a straight memberconnecting the legs or may form an apex. Moreover, the legs may extendsubstantially perpendicular from the crown or at some angle therefrom.Irrespective of the particular configuration, however, conventionalstaples are designed so that they may be deformed to hold body tissue.

Accordingly, the stapler applicators have conventionally embodiedstructure functioning to project the conventional staple into tissue aswell as to deform the staple so that it is retained against the tissue.Generally speaking, typical applicators include an anvil cooperatingwith means to eject the conventional staple from the applicator. In someapplications, access to the body tissue from two opposite directions isavailable and the anvil can operate to deform the legs of the stapleafter they have passed through the body tissue. In applications whereaccess to the tissue is from only one direction, the anvil may deformthe crown of the conventional staple so that its legs will project intothe body tissue in a fashion so as to hold the staple against thetissue.

Since conventional staples require deformation and must cooperate withapplicators having an anvil or other means to deform the staples,conventional applicators typically comprise complex structures and canbe prohibitively expensive. Conventional applicators must embodystructure functioning to not only eject the fasteners but to do so in amanner so that the fastener deforms properly and timely.

In some applications, conventional applicators must be equipped withstructure functioning to move the anvil into and out of position so thatwhen the fastener is ejected from the applicator, the anvil is properlypositioned and once fastener deformation is complete, moves out ofposition, thereby allowing the process to be repeated. Moreover, theanvil must be formed into a proper configuration so that fastenerdeformation can be repeated accurately. Further, the force between thefastener and the anvil must be controlled so that repeated deformationis accomplished. The objectives of many inventions in this field havebeen to accomplish these goals by the simple manipulation of a singlelever. It is to be appreciated, therefore, that the fastener applicatorshave become complex and expensive instruments.

Two part fasteners have also been conventionally utilized, where abarbed staple is used in conjunction with a retaining piece to hold thestaple in place. Typically, the two part staple comprises a crown orbackspan and two barbed prongs which are engaged and locked into aseparate retainer piece. In use, the staple is pressed into the bodytissue so that the barbs penetrate the tissue and emerge from the otherside where they are then locked into the retainer piece. Retainersprevent the staple from working loose from the tissue. The two piecefasteners cannot be unlocked and are not removable.

Like other conventional applications, however, the two piece fastenersrequire the staple delivery apparatus to have access to both sides ofthe tissue. Thus, as with the other conventional applications, two piecefasteners are limited since they cannot be used where access to tissueis from one direction only.

In those situations where access to body tissues is limited to onedirection, as in grafting procedures, deformable surgical fasteners havebeen conventionally employed. As mentioned previously, however; theapplicators commonly used in these situations embody an anvilcooperating with a fastener to deform it and consequently, tend to be ofa complex design.

Some advancements have been made in this area so that applicatorsfunctioning to attach grafts to tissue, for instance, are not requiredto embody an anvil and may, therefore, have a more simple design. Inparticular, it has been suggested in the art to employ fasteners withbarbs, thereby eliminating the need for deforming the fastener. Thesefasteners are limited, however, since the path created in the graft andtissue by the barbs as the fastener is pressed into the graft and tissuemay allow the fastener to loosen its grip or to entirely back out ofengagement. Moreover, due to their sole reliance upon barbs to retaintissue, the barb fasteners are further limited in that they may not havea great enough retentive surface area for securely holding tissue inplace.

To circumvent or overcome the problems and limitations associated withconventional fasteners and applicators, a simple applicator thatdispenses a surgical fastener having high surface area for retentivecontact with tissue and that can be delivered into body tissue from onedirection may be employed. The present invention embodies thesecharacteristics.

SUMMARY OF THE INVENTION

The invention includes a surgical fastener and an applicator used indelivering the fastener into body tissue. The fastener and applicator ofthe present invention may be used in a number of medical proceduresincluding ligating tissue, hernia mesh repair, bladder neck suspension,and in conjunction with implant drug delivery systems or proceduresinvolving positioning of surgical or implantable devices in a patient'sbody.

The preferred embodiment of the surgical fastener of the presentinvention is formed into the configuration of a continuous helical coil.The continuous helical coil is longitudinally collapsible andexpandable. At the distal end of the helical fastener is a point forenhancing penetration into tissue. The proximal end of the helicalfastener has a T-bar which sections the diameter of the fastener,thereby providing a surface for receiving and transmitting longitudinaland rotational forces so that the fastener may be driven into tissue bya corkscrew action. The pitch and length of the helical fastener mayvary upon the application as can its diameter and configuration of themost proximal and distal coils comprising the fastener. Additionally,the material selection and fastener stiffness may be selected with aparticular application in mind.

In another embodiment of the surgical fastener, the fastener comprises adouble continuous helical coil that is also longitudinally collapsibleand expandable and may embody various configurations depending upon theapplication. Moreover, the distal end of the double helical fastenercomprises two points for enhancing penetration into tissue and itsproximal end comprises a connector bar which connects the two helixes aswell as sections the diameter of the double helical fastener. In yetanother embodiment, the surgical fastener further comprises a pivot postextending through the center of the fastener and operating to providethe fastener with a stable pivot. In any of the embodiments, one or morebarbs may be employed near the point to enhance anchoringcharacteristics.

A preferred embodiment of the fastener applicator of the presentinvention includes a proximal portion and a distal portion. The proximalportion is preferably fabricated to be a “reusable” component and thedistal portion a “disposable” component. Alternatively, both the distaland proximal portion can be made disposable. The distal portion iselongate and embodies an outer tube housing an inner rotator, a lockclip/indicator and a load spring. The proximal portion includes ahandle. In the preferred embodiment of the distal portion, a thread formcomprising an interlock spring is provided within the outer tube. Therotator includes a structure running longitudinally along its lengththat functions to receive the T-bar or connector bar of the fastener andin this way, the rotator may hold a plurality of fasteners. The loadspring applies a force against the lock clip/indicator operating to biasthe plurality of springs distally within the outer tube and towards thenose piece. The thread form functions to engage the coils of the helicalfasteners and when rotating the rotator, a fastener is driven from thedistal end of the applicator. In other embodiments of the applicator,the distal end has various other structures functioning to engage thecoils of the fastener and to drive them from the distal end of theapplicator. In one other embodiment, the distal end comprises a nosepiece protrusion for engaging the fastener.

In order to cause the rotator to rotate, the proximal portion of theapplicator has a handle and an actuator cooperating with the rotator. Ina preferred embodiment, the proximal portion of the applicator embodiesa lever pivotally attached about a midpoint to the handle. A first endof the lever is configured to be gripped by hand and a second-end isadapted to engage a nut driver. The nut driver travels along a helicallead screw which is connected to the rotator. When the lever is squeezedby hand the nut driver travels along the lead screw causing it torotate, and through the connection of the lead screw to the rotator, theaction of the lead screw causes the rotator to rotate.

Further, the lever comprises a midsection extension. Pivotally attachedto the midsection extension of the lever is a spring loaded pawl adaptedto releasably engage gear teeth formed in the interior of the handle.The spring loaded pawl prohibits the lever from backstroking until ithas been completely depressed. Upon complete depression of the lever,the pawl clears the gear teeth and the spring, biasing the pawl, rotatesthe pawl away from the teeth, thereby allowing the lever to return toits undepressed condition.

In another embodiment of the proximal portion of the applicator, thelever is pivotally attached at a first end to the handle, the second endbeing adapted to engage the nut driver. Further, rather than embodying aspring loaded pawl, this alternate embodiment of the proximal portionincludes a clutch assembly or releasable connection between the leadscrew and rotator and cooperating means to prohibit the lever frombackstroking until it has been completely depressed.

Other features and advantages of the present invention will becomeapparent from the following detailed description, taken in conjunctionwith the accompanying drawings, which illustrate, by way of example, theprincipals of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts a perspective view of a fastener of the presentinvention, illustrating a side view of a helical fastener.

FIG. 1A depicts another perspective view of the fastener of the presentinvention, illustrating an end view of the helical fastener.

FIG. 1B depicts a schematic view of a fastener of the present invention,illustrating a substantially collapsed helical fastener with arelatively small gap that has been partially inserted into tissue.

FIG. 1C depicts a schematic view of a fastener of the present invention,illustrating the helical fastener depicted in FIG. 1B completelyinserted into tissue.

FIG. 1D depicts a schematic view of a fastener of the present invention,illustrating a substantially collapsed helical fastener with arelatively large gap that has been partially inserted into the tissue.

FIG. 1E depicts a schematic view of a fastener of the present invention,illustrating the helical fastener depicted in FIG. 1D completelyinserted into tissue.

FIG. 1F depicts a perspective view of another embodiment of the presentinvention, illustrating an end view of the helical fastener.

FIG. 2 depicts a perspective view of another embodiment of the presentinvention, illustrating a double helical fastener.

FIG. 2A is a front view of the double helical fastener of FIG. 2.

FIG. 2B is side view of the double helical fastener of FIG. 2.

FIG. 2C is a top view of the double helical fastener of FIG. 2.

FIG. 3 is a perspective view of yet another embodiment of the presentinvention, illustrating another design of a double helical fastener.

FIG. 3A is a front view of the double helical fastener of FIG. 3.

FIG. 3B is a side view of the double helical fastener of FIG. 3.

FIG. 3C is a top view of the double helical fastener of FIG. 3.

FIG. 4 is a perspective view of the present invention, illustrating ahelical fastener with a central post.

FIG. 5 depicts a schematic cross-sectional view of an applicator of thepresent invention, illustrating a side view of the applicator.

FIG. 6 is a schematic cross-sectional side view of a terminal end of theapplicator.

FIG. 6A is a schematic cross-sectional end view of a terminal end of theapplicator.

FIG. 7 is a schematic cross-sectional view of the terminal end of theapplicator, illustrating the preferred embodiment of the terminal end.

FIG. 7A is a schematic cross-sectional end view of the preferredembodiment of the terminal end of the application shown in FIG. 7.

FIG. 8 is a schematic cross-sectional view of the terminal end of theapplicator, illustrating another embodiment of the terminal end.

FIG. 8A is a schematic cross-sectional end view of the embodiment of theterminal end of the applicator shown in FIG. 8.

FIG. 9 is a schematic cross-sectional view of the terminal end of theapplicator, illustrating yet another embodiment of the terminal end.

FIG. 9A is a schematic cross-sectional end view of the embodiment of theterminal end of the applicator shown in FIG. 9.

FIG. 10 is a schematic cross-sectional view of the terminal end of theapplicator, illustrating still yet another embodiment of the terminalend.

FIG. 10A is a schematic cross-sectional end view of the embodiment ofthe terminal end of the applicator shown in FIG. 10.

FIG. 11 is a schematic cross-sectional view of the terminal end of theapplicator, illustrating another embodiment of the terminal end.

FIG. 11A is a schematic cross-sectional end view of the embodiment ofthe terminal end of the applicator shown in FIG. 11.

FIG. 12 is a schematic cross-sectional view of the terminal end of theapplicator, illustrating a further embodiment of the terminal end.

FIG. 12A is a schematic cross-sectional end view of the embodiment ofthe terminal end of the applicator shown in FIG. 12.

FIG. 13 is a schematic cross-sectional view of the terminal end of theapplicator, illustrating a still further embodiment of the terminal end.

FIG. 14 is a schematic cross-sectional view of the terminal end of theapplicator, illustrating still yet another embodiment of the terminalend.

FIG. 15 is a schematic cross-sectional view of another applicator of thepresent invention, illustrating a side view of the applicator.

FIG. 16 is a schematic partial cross-sectional view of a releasableconnection between the lead screw and rotator.

FIG. 16A is schematic representation of a distal end of the lead screw,illustrating an end view of the lead screw.

FIG. 16B is a schematic representation of the distal end of the leadscrew, illustrating a side view of the lead screw depicted in FIG. 16.

FIG. 16C is a schematic representation of the proximal end of therotator, illustrating a side view of the rotator.

FIG. 16D is a schematic representation of the proximal end of therotator, illustrating an end view of the rotator depicted in FIG. 16B.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

As is shown in the drawings, which are included for purposes ofillustration and not by way of limitation, the invention is embodied ina continuous helical fastener and an applicator therefor. The helicalfastener has a high retentive surface area and the applicator has asimple design and functions to dispense the helical fasteners, withoutsubstantially deforming the fasteners, into body tissue, access to whichis from one direction only. Some conventional fasteners requiredeformation to hold tissue and are consequently limited sine theyrequire complex applicators to attach them into tissue. Otherconventional fasteners lack high retentive surface area for securelyholding tissue. Still other fastener/applicator systems require accessto tissue from two directions in order to accomplish attaching afastener to tissue. Thus, the helical fastener and applicator of thepresent invention provides a superior means to attach fasteners totissue.

One embodiment of the present invention (FIGS. 1, 1A and 5) is embodiedin a helical fastener 10 which is attached to tissue by employing anovel applicator 12 which rotates the fastener 10 into tissue. Thedimensions and physical characteristics of the helical fastener 10 areselected to insure a secure attachment of the fastener 10 to tissue.Similarly, the dimensions and physical characteristics of the applicator12 utilized to dispense the fasteners 10 into tissue are dependent uponthe application.

In a preferred embodiment, the fastener 10 is formed into theconfiguration of a continuous helix and may have a depth 16, a diameter18 and a pitch 20 determined by the application. The continuous helixmay be longitudinally collapsible and expandable. The cross-sectionalprofile of the continuous helix is substantially circular in thepreferred embodiment but can be square, rectangular or triangular. In aparticular application such as mesh anchoring for hernia repair, thepre-formed pitch can be 0.050 inches. However, the preformed pitch canvary from 0 to a maximum of approximately 3.0 times the coil diameter.In other embodiments, it is contemplated that the pitch 20 vary alongthe length of the fastener 10 so as to optimize the retaining force ofthe fastener 10. Moreover, since the continuous helical coil ispreferably longitudinally collapsible and expandable, upon insertioninto tissue, the final pitch 31 may be less than or greater than thepre-formed pitch. If the coil is made of rigid construction, as is alsocontemplated, pitch would be made substantially fixed. The diameter inthe preferred embodiment may be 5 mm; however, designs ranging from 1 mmand up are contemplated. In practice, the depth 16 of the fastener 10must be selected so that the extent of fastener penetration into tissueis sufficient to hold the fastener 10 in place.

Moreover, distal end 22 of the fastener 10 is to be configured such thata gap 23 exists between the most distal coil 27 (or first coil) of thefastener 10 and its adjacent coil. As may be appreciated from thepreferred embodiment of FIGS. 1B through 1E, as the fastener 10 ispressed against tissue 25, all of the coils substantially collapseexcept the most distal coil 27, leaving the gap 23 to determine the paththe fastener 10 takes as it is rotated into the tissue 25 and moreimportantly, the extent of penetration 29 into the tissue 25 and finalpitch 31 of the fastener 10 in tissue. Although FIG. 1B showssubstantially all of the coils being collapsed, it is to be appreciatedthat, depending upon the applicator utilized to implant the fastener 10,fewer coils than all of the coils may be collapsed at any one time. Itremains, however, that since the fastener 10 is longitudinallycollapsible and expandable, it is the gap 23 that generally determinesfinal pitch 31. Accordingly, the magnitude of the gap 23 can be varied,depending upon the application, to achieve the desired final pitch 31and penetration 29 in tissue. Thus, the greater the gap 23, uponinsertion of the fastener 10 in tissue, the greater the penetration 29and final pitch 31 of the fastener 10 in tissue.

In the preferred embodiment, the distal end 22 of the helical fastener10 terminates with a point 24. The point 24 may be sharp or bluntdepending upon the tissue to which the fastener 10 will be affixed.Additionally, one or more barbs or a sharp point projecting in reversedirection to point 24 (not shown) can be added to fastener 10 near point24 to enhance anchoring characteristics of the fastener. A proximal end26 of the helical fastener 10 may comprise structure functioning toreceive and transmit applied longitudinal forces. In the preferredembodiment, the most proximal coil is formed into a T-bar 33 thatperpendicularly sections the diameter 18 of the fastener 10. Inalternate embodiments, it is also contemplated that the most proximalcoil section the diameter 18 non-perpendicularly or be formed into aspiral 35 existing in a single plane (See FIG. 1F).

Concerning the material of the helical fastener 10, it is contemplatedin the preferred embodiment that the fastener be made from semi-stiffimplantable wire, such as titanium, wound into a helical shape. Inalternate embodiments, the helical fastener 10 may comprise plastic orabsorbable materials. Examples of materials that can be used inconstructing the helical fastener 10 include titanium, titanium alloys,stainless steel, nickel, chrome alloys and any other biocompatibleimplantable metals. Other options for materials are liquid crystalpolymers, HDPE, polyglycolic acid, and polyglycolid hydroxgacetic acid.Further, it may also be desirable to coat the fastener, or a portionthereof, with a biocompatible lubricious material that provides foreasier delivery of the fastener into tissue.

In another embodiment of the surgical fastener, the fastener 110 isformed into the configuration of a double helix (See FIGS. 2-2C). Byembodying a double helix, the fastener 110 has increased retentivestrength as well as means to balance the fastener 110 as it is pressedinto tissue. As with the helical fastener 10, the configuration of thedouble helical fastener 110, i.e., the pre-formed pitch and diameter,may be varied for a particular application and a barb may be employed toenhance anchoring in tissue. Moreover, the materials contemplated arethe same as those for the helical fasteners. Further, the double helicalfastener 110 is also longitudinally collapsible and expandable and itsfinal pitch is dependent upon the gap 112 existing between the mostdistal coils 114, 115 of the fastener 110 and their adjacent coils.

Regarding the proximal 118 and distal 120 ends of the double helicalfastener 110, they comprise structure to drive the fastener into tissueas well as tissue piercing structures. The proximal end 118 has aconnector bar 122 sectioning the diameter of the fastener that connectsone helical coil to another and functions to receive and transmitlongitudinal forces. The distal end 120 terminates with two points 124,125 for piercing and facilitating the implantation of the fastener 110into tissue.

As may be appreciated by comparing FIGS. 2-2D with FIGS. 3-3D, it iscontemplated that the double helical fastener 110 have a full turndesign (FIGS. 2-2D) as well as a half turn design (FIGS. 3-3D). It is tobe understood, however, that the designs having more than one turn andhaving other increments of turns are contemplated. It is the applicatorthat will determine the required number of turns for a specific fastener110.

In yet another embodiment of the surgical fastener, as shown in FIG. 4,the double helical fastener 110 is provided with a pivot post 130 havinga pointed terminal end 132. The pivot post 130 of this embodimentoperates to provide the fastener 110 with a stabilizing element so that,as the fastener 110 is being turned, the helical coils cooperativelyenter the tissue.

The applicator 12 (FIG. 5) comprises a proximal portion 28 having ahandle 30 and an actuator 32 and a cooperating elongated distal portionor cannula 34 housing a plurality of fasteners. In general, through themanipulation of the actuator 32, the fasteners are ejected, one by one,out of a distal portion 34 and into body tissue. The applicator 12,hereinafter described in more detail, is equally proficient in drivingeach of the embodiments of fasteners set forth above into tissue.

In more detail (see FIGS. 6 and 6A), the distal portion 34 comprises anouter tube 36 housing a rotator 38, a lock/clip indicator 40 and a loadspring 42. Extending longitudinally along the rotator 38 is a groove 44which operates to receive the most proximal coil sectioning thefastener. Although FIG. 6 shows only a single fastener (having a singlehelical design) retained by the rotator 38, it is to be appreciated thatthe rotator 38 may receive a plurality of fasteners (having a single ordouble helical design), wherein each fastener has its last coilpositioned within the rotator groove 44. Moreover, although not depictedin FIG. 3, it is also contemplated that rather than embodying a groove,the rotator 38 has a cross-sectional profile approximately a “D”,wherein the flat portion operates to engage the coil sectioning thefasteners. Irrespective of the configuration of the rotator, however,the rotator is to embody structure functioning to engage a plurality offasteners and to facilitate turning them into tissue.

It is also to be appreciated that load spring 42 applies a force throughthe lock clip indicator 40 to bias the plurality of fasteners distally.The lock clip/indicator 40 may comprise a simple washer sized and shapedto engage the fasteners and rotator 38 as well as to receive forces fromthe load spring 42. Additionally, lock/clip indicator 40 serves as a jamstop to prevent further actuation by rotator 38 upon discharge of allfasteners by mating with, or abutting against, structure comprising theterminal end 50 and preventing further rotation. Lock/indicator 40 canbe made of a color (or shape) to serve as an empty indicator notifyingthe user that no more fasteners are available other embodiments of theindicator 40 may be utilized as long as they function to transmit forcesto bias the fasteners distally. The load spring 42 is to be retainedwithin the outer tube 36 and to have physical characteristics such thatsufficient forces may be applied through a front end 43 to a lastremaining fastener contained within the applicator 12. A back end (notshown) of the load spring 42 may be placed against any stationerystructure within the outer tube 36, thereby providing a foundationagainst which the spring 42 may be compressed. In a preferredembodiment, the load spring 42 extends substantially the length of thedistal portion 34.

In the preferred embodiment (FIGS. 7 and 7A), the outer tube 36 isconfigured with a thread form 201 comprising an interlock spring 203fixedly retained within the outer tube 36 and extending substantiallythe length thereof. The interlock spring 203 may be fixedly retainedwithin the outer tube 36 by ensuring a tight interference between theparts or the interlock spring may be spot welded or equivalently bondedwithin the outer tube. The thread form 201 operates to guide thefasteners through the distal portion 34 and to eject them from theapplicator 12.

In another embodiment of the applicator 12 (FIGS. 8 and 8A), attached ata terminal end 46 of the distal portion 34 may be a nose piece 48. Thenose piece 48 may further comprise a protrusion 50 extendingperpendicularly and towards a longitudinal axis 52 of the distal portion34. This nose piece protrusion 50 also functions to engage the surgicalfasteners and to force them from the terminal end 46 of the distalportion 34 as well as engaging lock/clip indicator 40 as describedabove.

In other embodiments of the applicator 12, the distal portion embodiesother structure or thread forms functioning to engage the surgicalfasteners and guide them out of the applicator and into tissue (SeeFIGS. 9-14). In FIGS. 9 and 9A, the outer tube 36 is rolled at itsterminal end 46 and a 180° portion of the rolled terminal end is cutaway. The remaining roll d portion engages the fastener while theportion cut away provides an exit for the fasteners. The embodimentdepicted in FIGS. 10 and 10A is similar to that of FIGS. 9 and 9A, thedifference being that instead of removing a portion of the rolledterminal end 46, it is stamped or deformed to thereby provide an exit.FIGS. 11 and 11A show yet another embodiment, wherein two longitudinallyspaced apart stabilizing points 301, 302 are formed 180° from each otherwithin the outer tube. These stabilizing points also operate to engagethe fastener and guide it into tissue. Turning to FIGS. 12, 12A, 13 and14, they each comprise a terminal end 46 formed with threads whichoperate to engage and eject a fastener. In FIGS. 12 and 12A are depictedthreads machined or formed solely within the inside of the outer tube.FIG. 13 shows an internally threaded sleeve attached to the outside ofthe terminal end 46 of the outer tube 36. FIG. 14 illustrates anapplicator 12 provided with a terminal end 46 deformed so as to haveinternal and external threaded structures. Irrespective of the designchosen for the terminal end of the applicator, however, each of thedesigns are effective with a relatively small overall outer diameter,i.e., on the order of 5 mm.

In order to eject surgical fasteners from the distal portion 34, theactuator 32 functions to turn the rotator 38. As the rotator turns, thedistal end 22 of a fastener is threaded out of the terminal end 46 ofthe applicator 12 (see FIG. 5).

In the preferred embodiment of the proximal portion 28 of the applicator12 (See FIG. 5), a lever 54 is pivotally connected about a midpoint 56to the handle 30. A first end 58 of the lever 54 is to be configured forgripping by hand. A second end 60 of the lever is to be adapted topivotally engage a nut driver 62.

The nut driver 62 of the applicator 12 travels upon a high helix leadscrew 64 which is rotatably mounted within the proximal portion 28. Inthe preferred embodiment, a longitudinal axis of the high helix leadscrew 64 is coaxial with the longitudinal axis 52 extending through thedistal portion 34 of the applicator 12. Upon manipulation of the lever54, the nut driver 62 travels along the lead screw 64 causing it torotate through a connection of the lead screw 64 to the rotator 38, theaction of the lead screw causes the rotator to rotate. The lead screw 64may be connected to the rotator 38 by any conventional means. Forinstance, the lead screw 64 can have an internal bore receiving andengaging an end of the rotator 38. Further, the length of travel of thenut driver 62 along the lead screw 64 is chosen such that it causes therotator to rotate a predetermined number of times so that a singlehelical fastener 10 is ejected from the applicator 12.

Additionally, in the preferred embodiment, the lever further comprises amidsection extension 66. Pivotally attached to the midsection extension66 of the lever 54 is contemplated to be a spring loaded pawl 68 adaptedto releasably engage gear teeth 70 formed in the interior of the handle30. Spring loaded pawl 68 is configured to prohibit the lever 54 frombackstroking until it has been completely depressed. Upon completedepression of the lever 54, the pawl 68 clears the gear teeth 70 and thespring biasing the pawl 68 rotates the pawl 68 away from the teeth 70,thereby allowing the lever 54 to return to its undepressed condition.

In operation, upon complete depression of the lever 54, the nut driver62 travels a pre-determined distance along the lead screw 64, causingthe rotator 38 to rotate a pre-determined number of revolutionscorresponding to a number of turns of a particular helical fastener 10.As the rotator 38 rotates, the fasteners retained by the rotator alsorotate and the coils of the most distal fastener are threaded out of theterminal end 46 of the applicator 12 and into tissue. Moreover, wherethe lever 54 is only partially depressed, the spring loaded pawl 68operates to hold the lever 54 stationery and will continue to functionto hold the lever 54 stationery until the lever 54 has been completelydepressed. In this way, the delivery of fasteners into body tissue iscontrolled so that only a single fastener may be completely ejected outof the applicator 12 and pressed into body tissue at a time.

In the preferred embodiment, the proximal portion 28 is fabricated tohave a reusable handle that can be re-sterilized, and the distal portionis made disposable. Thus, upon discharge of all the fasteners 10 fromdistal portion 34, the distal portion would be discarded and replaced.The handle could be reused up to a limited number of procedures.

In another embodiment of the proximal portion 328, of the applicator 312(FIG. 15), a lever 354 is pivotally connected at a first end 355 to thehandle 330 and biased to its undepressed position by a spring 357. Themid-section 358 of the lower 354 is configured for gripping by hand. Asecond end 360 of the lever is to be adapted to pivotally engage a nutdrive 362.

The nut driver 362 of the applicator 312 travels along a high helix leadscrew 364 which is rotatably mounted within the proximal portion 328.Upon manipulation of the lever 354, the nut driver travels along thelead screw 364 causing it to rotate and, through a clutch assembly or areleasable connection of the lead screw 364 to the rotator 38, theaction of the lead screw causes the rotator to rotate.

Further, the lever 354, has a mid-section extension 366 that cooperateswith a spring biased latch pawl mechanism 368 fixed to the handleadapted to releasably engage teeth 370 formed on the mid-sectionextension 366. The spring biased latch pawl is configured to prohibitthe lever 354 from backstroking until it has been completely depressed.Upon complete depression of the lever 354, the latch pawl 368 clears themid-section teeth 370 and the spring biased latch pawl 368 rotates awayfrom the teeth, thereby allowing the lever 354 to return toits-undepressed condition.

As stated, there is a releasable connection between the lead screw 364and the rotator. The releasable connection provides the applicator withmeans to disengage the distal portion of the applicator from theproximal portion. In this way, the proximal portion can be re-used withvarious different designs of the proximal portion. Further, while thelever 354 is being depressed, the clutch assembly or releasableconnection functions to transfer the rotation of the lead screw 364 tothe rotator 38, thereby causing the rotator to rotate. Additionally,upon complete depression of the lever, the clutch assembly operates toallow relative motion of the lead screw 364 and the rotator.

One such releasable connection contemplated is a conventional ratchetmechanism. As shown in FIGS. 16-16D, the distal end 370 of the leadscrew 364 has a connecting surface 372 equipped with leaf springs 374,376 each having an engaging face 377 and an internal bore 378 existingcoaxially with a longitudinal axis of the lead screw. The proximal end380 of the rotator 38 has a cooperating connecting surface 382 havingridges 384 for releasable engagement with the leaf springs 374, 376 andan extension 386 adapted to fit within the internal bore of the leadscrew connecting surface. As may be appreciated from the FIGS., as thelead screw turns so that the ridges 384 contact the engaging faces 377of the leaf springs 374, 376, the rotation of the lead screw 364 willcause the rotator 38 to likewise rotate. Where the lead screw is turnedin the opposite direction, the ridges 384 will not engage the engagingface of the leaf springs and the motion of the lead screw 384 will notbe transferred to the rotator 38.

In this embodiment, upon complete depression of the lever 354, the nutdriver 362 travels a pre-determined distance along the lead screw 364,causing the rotator 38 to rotate a pre-determined number of revolutions.As the rotator 38 rotates, the fasteners retained by the rotator alsorotate and the coils of the most distal fasteners are threaded out ofthe applicator and into the tissue. At this point, the latch pawlmechanism 368 disengages from the teeth 370 and the lever 354 isreturned to its undepressed position by spring 357. As with the previousembodiment of the proximal portion 28, the proximal portion of thisembodiment functions to allow only a single fastener to be completelyejected from the applicator and be pressed into body tissue at a time.

In other embodiments, means to cause the rotator to rotate may comprisea single knob connected to a rotator which can be turned by hand.Additionally, the revolving means may include a rack and gear structureor a set of beveled gears. Further, instead of comprising a groove, therotator may be internally threaded, wherein the threaded portionsfunction to house as well as advance the helical fasteners 10.Irrespective of the means or structure employed, however, it iscontemplated that the number of revolutions of the rotator be set to apre-determined parameter so that the delivery of helical fasteners totissue may be controlled.

From the foregoing, it will be appreciated that the helical fastener inapplicator of the present invention functions to securely attach afastener with high retentive surface area to tissue from one directionthrough the utilization of an applicator having a simple design. It isalso to be appreciated that the present invention may be utilized in anumber of applications including ligating tissue, hernia mesh repair,bladder neck suspension, and in conjunction with implant drug deliverysystems or procedures involving positioning of surgical or implantabledevices in patient.

While several particular forms of the invention have been illustratedand described, it will also be apparent that various modifications canbe made without departing from the spirit and scope of the invention.

Thus, it should be understood that various changes in form, detail andapplication of the present invention may be made without departing fromthe spirit and scope of this invention.

What is claimed is:
 1. An applicator comprising: a distal portion havingan elongate outer tube, a connecting end and a terminal end; a proximalportion having a handle and an actuator, the proximal portion beingattached to the connecting end of the distal portion; a plurality offasteners; a thread form contained in an interior of the terminal endadapted to engage the plurality of fasteners; and a rotator cooperatingwith the actuator, the rotator including a longitudinal groove extendingalong at least a portion thereof, the groove configured to receive aportion of at least two fasteners of the plurality of fasteners, whereinthe rotator resides within and extends substantially the length of theouter tube such that actuation of the actuator results in rotation andtranslation of the at least one fastener relative to the outer tubewhile the rotator remains longitudinally stationary with respect to theouter tube such that actuation of the rotator ejects at least onefastener of the plurality of fasteners from the terminal end.
 2. Theapplicator of claim 1 further comprising: a lock/clip indicator engagingthe plurality of fasteners; and a load spring for applying longitudinalforces against the lock/clip indicator.
 3. The applicator of claim 2,wherein the lock/clip indicator is configured to prevent actuation ofthe actuator upon discharge of the plurality of fasteners from theapplicator.
 4. The applicator of claim 1, wherein the thread form is aninterlock spring fixedly retained in the interior of the terminal end.5. The applicator of claim 1 further comprising: a nose piece attachedto the terminal end, the nose piece having structure projectingperpendicularly toward a longitudinal axis of the outer tube and adaptedto engage the plurality of fasteners.
 6. The applicator of claim 1,wherein the distal portion and the proximal portion are releasablysecured together.
 7. The applicator of claim 6, wherein the distalportion is disposable and the proximal portion is reusable.
 8. Theapplicator of claim 1, wherein the actuator includes: a lever having afirst end and a second end, the lever pivotally attached about amidpoint to the handle: the first end of the lever for gripping by hand;a lead screw rotatably attached to an interior of the handle: a nutdriver, the second end of the lever pivotally attached to the nutdriver, the nut driver for traveling along the lead screw, therebyturning the lead screw; and the lead screw attached to the rotator sothat as the lever is depressed by hand the nut driver will travel alongthe lead screw towards the rotator thereby turning the rotator in theprocess.
 9. The applicator of claim 8, wherein the lead screw is a highhelix lead screw.
 10. The applicator of claim 8, wherein the lever has amidsection extension.
 11. The applicator of claim 10, further comprisinggear teeth formed within the interior of the handle.
 12. The applicatorof claim 11, further comprising a spring loaded pawl pivotally attachedto the midsection extension and adapted to engage the gear teeth. 13.The applicator of claim 1, wherein the actuator includes: a lever havinga first end, a midsection, and a second end, the first end pivotallyattached to the handle, the midsection for gripping by hand; a leadscrew rotatably attached to an interior of the handle; a nut driver, thesecond end pivotally attached to the nut driver, the nut driver fortraveling along the lead screw, thereby turning the lead screw; andmeans for the lead screw to releasably engage the rotator so that as thelever is depressed by hand, the nut driver will travel along the leadscrew toward the rotator thereby turning the rotator in the process andso that when the lever is returned to its undepressed position, the leadscrew will rotate in the reverse direction and independently of therotator which remains stationary.
 14. The applicator of claim 13,wherein the lead screw is a high helix lead screw.
 15. The applicator ofclaim 13, wherein the releasable engagement means is a ratchetmechanism.
 16. The applicator or claim
 13. wherein the lever has amid-section extension, formed in the mid-section extension are aplurality teeth.
 17. The application of claim 16 further comprising alatch pawl cooperating with the teeth to prohibit the lever frombackstroking until it has been completely depressed.
 18. The applicatorof claim 1, wherein the longitudinal groove is formed on an outersurface of the rotator.
 19. The applicator of claim 18, wherein thelongitudinal groove is substantially parallel to a longitudinal axis ofthe rotator.
 20. The applicator of claim 1, wherein at least onefastener of the plurality of fasteners is formed from an absorbablematerial.
 21. An applicator comprising: an actuator; a rotatoroperatively coupled to the actuator, the rotator having a longitudinalgroove; a plurality of fasteners disposed about the rotator, eachfastener having a portion thereof positioned within the longitudinalgroove of the rotator; an outer tube surrounding at least a portion ofthe rotator, wherein actuation of the actuator results in rotation andtranslation of each fastener of the plurality of fasteners relative tothe outer tube and the rotator remains axially stationary with respectto the outer tube and a thread form contained in an interior of aterminal end of the outer tube, the thread form adapted to engage theplurality of fasteners.
 22. The applicator of claim 21, wherein therotator is configured to eject each fastener and the longitudinal grooveis configured to releasably receive the portion of each one of theplurality of fasteners.
 23. The applicator of claim 21, wherein thelongitudinal groove is adapted to slidably receive the portion of eachone of the plurality of fasteners.
 24. The applicator of claim 21,wherein at least a portion of each one of the plurality of fastenerssurrounds the rotator.
 25. The applicator of claim 21, wherein at leastone fastener of the plurality of fasteners is formed from an absorbablematerial.
 26. The applicator of claim 21, wherein actuation of therotator ejects at least one fastener of the plurality of fasteners fromthe terminal end.